A recent conversation from my IRB work—for several reasons, I must limit the details of the case:
An IRB had received, for review and approval, a research protocol for gene editing of human embryos obtained from an IVF clinic. The embryos would be at about the 150-cell stage—an early stage at which some (incorrectly, as I understand the science) believe a fertilized, dividing-and-differentiating zygote has not yet attained sufficient maturity to be called an embryo. These embryos would have been “donated,” in compliance with current law and regulation, including informed consent from the relevant party or parties. Further, the embryos would have been found to have a “life-threatening” mutation by preimplantation genetic diagnosis (PGD).
The first impression of the IRB’s primary reviewer (a scientific member for you readers familiar with regulations about the makeup of an IRB) was that the study was approvable on an expedited basis—that is, without a discussion at a full IRB meeting. Current regulations identify nine categories of research eligible for expedited review. The study in question arguably fits criterion #3: “Prospective collection of biological specimens for research purposes by noninvasive means.”
Under current law and regulation, this is a reasonable view. The Code of Federal Regulations (45 CFR 46.204) includes requirements for the protection of live human fetuses who are subjects of research. The regulations define “fetus” as “the product of conception from implantation until delivery.” Research involving dead fetuses, in whole or in part, including those obtained as a result of elective abortion, is to “be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.” As the Congressional Research Service points out in a general reader-friendly FAQ document (go to https://www.fas.org/sgp/crs/misc/R44129.pdf), any research involving human subjects must be approved by an IRB in advance, but the dead fetus is not considered to be a human subject.
It’s logical to apply the same considerations to embryos used in research, and PGD, and, to be sure, IVF itself. Of course, these embryos are usually destroyed in the process, and all the related issues of embryo or fetal tissue donation are raised in the process. In the present case, were the research to be done on embryos intended for implantation and bearing in pregnancy, the embryos would be human subjects as well, and all the related issues—consent and others—that I and others have discussed on this blog in the past would apply as well. It’s arguable that, to be sure all regulations are met, an IRB should send research like the proposal in this case to full review. (One question I would have is how strict is the definition of “life threatening” mutation.)
For those who, like me, argue that human life begins at conception and might like to see the current regulations changed, that probably would require a new statute—a law passed by Congress and signed by the president.
But none of those thoughts is my main concern here. Rather, I think of the recent discussions of whether it is wise to edit the genes of human embryos or germline cells (eggs or sperm). Scientists meeting in Washington DC recently issued a statement that it would be “irresponsible” to proceed with such editing in embryos intended for pregnancy. There appeared to be at least a cautious embrace of basic research on editing genes in these cases, however, implying support for proposals like the one crudely outlined here. But some leading scientists in the gene editing field disagree, arguing for a broader societal discussion first.
And, in that light, consider the shrinking role of the IRB. I think the standard understanding of the IRB’s jurisdiction, in the early 21st century, is narrow—it is empowered only to address whether current regulations are being met. Whatever the individual members of an IRB may think about the broader questions of the wisdom of forging ahead with human embryo or germline gene editing, I bet most IRBs would not think that it is not their business to weigh in on whether studies like the one described here should be done at all. In other words, whatever societal discussion of these ethical issues is needed, the IRB is walled off from it. Am I the only one who finds it ironic that IRBs, which had their genesis in the effort to prevent mistreatment of human research subjects, and whose members are required to have varying backgrounds, are considered unqualified to weigh in on matters like this?